Respiratory depression
Conditions
Interventions
Trade Name: Oxycodone
Product Name: Oxycodone
Product Code: RVG 27511
Pharmaceutical Form: Capsule
INN or Proposed INN: OXYCODONE
CAS Number: 76-42-6
Current Sponsor code: Oxycodone
Concentration unit
Sponsors
Leiden University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy sybjects - Aged 18-40 years (phase I) - Aged 75 years or older (phase II) - Body Mass Index 18-30 mm/kg2 - Subject is able to read and understand the written consent form, complete study related procedures and communicate with the study staff - Healthy and free of significant abnormale findings as determined by medical history, physical examination and vital signs - Subject is deemed suitable by the Investigator for inclusion in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Current diagnosis or history of psychiatric disease Current or chronic medical condition requiring the medication considered Cytochrome P-450 (CYP2E1, CYP2D6, CYP3A4) inductor or current use of opioid analgesics Current diagnosis or history of lung disease (i.e. asthma, COPD, tuberculosis) Exclusion based on medication use is subject to jugdment by investigators Participation in a clinical drug study during the 60 days preceding the initial dosing of this study Any history of frequent nausea or vomiting regardles of etiology Weekly alcohol intake exceeding the equivalent of 21 units/week or positive alcohol breath test during check-in Asian ethnicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess wheter sedation as measured by a VAS scale an BIS monitoring is increased in the alcohol conditions compared to the placebo condition. To assess wheter analgesia induced by oxycodone is affected by alcohol.;Primary end point(s): Observed respiratory depression while oxycodon20 mg is combined with placebo, alcohol 0.5 g/l or alcohol 1.0 g/l ;Timepoint(s) of evaluation of this end point: Ventilation is measured five times with a Vi-CO2 response curve. This is measured during baseline (no alcohol, no opioid), after start alcohol, after start opioids 3 times;Main Objective: To assess the respiratory effect of oxycodone when administered concomitantly with alchol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effect of alcohol on pressure pain measurements Effect of alcohol on level of sedation;Timepoint(s) of evaluation of this end point: Pressure pain measurement will be done at baseline, after start alcohol infusion, 60 min after infusion, 120 min after ingestion, 180 min after ingestion Sedation will be continyously measured with a BIS | — |
Countries
Netherlands
Contacts
Public ContactProf. Albert Dahan
Leiden University Medical Centre
Outcome results
None listed